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Introduction

Welcome to the SAHPRA Portal Internal User Guide

This guide provides step-by-step instructions for using the South African Health Products Regulatory Authority (SAHPRA) Engagement portal from an internal employee perspective.

Purpose of This Manual

The SAHPRA Engagement Portal (https://portal.sahpra.org.za/) is an online platform designed to facilitate interactions between applicants and the South African Health Products Regulatory Authority (SAHPRA). This portal enables users to submit and track applications, manage their profiles, and ensure compliance with regulatory requirements.

Because internal SAHPRA staff frequently need to assist applicants, manage system access, and oversee application workflows, this manual provides step-by-step guidance on how to effectively use the portal. This includes navigation, user account and organization management, and processing applications as a SAHPRA user.

Key Learning Objectives

By the end of this training, users will be able to:

  • Navigate the SAHPRA Engagement Portal efficiently.
  • Manage internal and external user profiles, including roles, access, and organization details.
  • Understand the process of managing, routing, and tracking various applications.

User Role Breakdown

Internal users have the ability to view and sometimes manage the roles assigned to both SAHPRA personnel and external applicants. Below is a comprehensive breakdown of all roles utilized within the system, categorized by their operational scope.

1. External / Industry Roles

These roles belong to external applicants and invited subject matter experts who interact with SAHPRA via the portal.

  • Individual: Individual users are applicants who are not part of a registered organization. They have access to submit, amend, or view any applications they personally action and can monitor their progress throughout the regulatory lifecycle.

  • Employee: Employees are users operating under a registered company. They are granted access to submit, amend, or view applications undertaken by that company. Depending on company preferences, some Employees may have restricted access limited solely to viewing applications and tracking progress within the company’s portfolio.

  • Organisation Administrator: Organisation Administrators possess comprehensive access to their company’s application processes. They can submit, amend, or view any company-initiated applications and monitor their status. Additionally, they are responsible for editing company details, managing individual employee profiles, and controlling user permissions to ensure appropriate access levels within their organization.

  • Clinical Trial - External Reviewer: External Reviewers are subject matter experts who are not direct SAHPRA employees but are formally invited into the system to assist with evaluations. They are granted restricted, targeted access solely to review the specific clinical trial applications assigned to them, allowing them to securely provide expert input and recommendations.

2. General Internal Administration

These roles manage the overarching system, financial operations, and departmental units at SAHPRA.

  • System Administrator: System Administrators hold the highest level of access within SAHPRA’s internal system. They have the authority to configure system-wide settings, such as pricing rules, and manage all internal users, external organizations, and external users. They possess full visibility over all applications, can create and manage units, perform all Unit Manager actions, and maintain core administrative controls.

  • Unit Manager: Unit Managers have full control over managing users within their assigned regulatory unit. They can add or remove users from the unit, oversee all applications routed to their department, and update application statuses. Unit Managers serve as the primary coordinators for their unit, with the ability to assign reviewers to applications and grant approvals where applicable.

  • Finance Admin: Finance Administrators have oversight of the financial components within the portal. This role provides dedicated access to the centralized payments dashboard across all application types, enabling users to track, verify, and manage financial transactions, invoices, and payment statuses related to all portal submissions.

3. Module-Specific Internal Roles

These roles are assigned to SAHPRA personnel executing specific technical reviews and workflows within designated modules (e.g., Clinical Trials, HPA, Section 21).

  • Section 21 - Reviewer: Section 21 Reviewers are internal users assigned to evaluate Section 21 applications. They have visibility into all such applications within their designated unit to assess submissions and provide regulatory input. They do not have the administrative ability to modify user roles or alter system configurations.

  • Grouped Variation Reviewer: Grouped Variation Reviewers are internal Health Products Authorisation (HPA) users focused specifically on post-registration amendments. They are responsible for evaluating grouped HPA variation requests, with the authority to review documentation and subsequently approve or reject the variation requests based on their assessment.

  • Clinical Trial - Reviewer: Clinical Trial Reviewers are internal SAHPRA personnel dedicated to the Clinical Trial Application (CTF1) module. Their primary responsibilities involve conducting the initial screening processes and performing comprehensive, in-depth technical reviews of clinical trial applications to ensure regulatory compliance.

  • Clinical Trial - Coordinator: Clinical Trial Coordinators have comprehensive oversight of the entire lifecycle of a Clinical Trial Application. They manage the workflow from the initial review stages through to the final decision. Coordinators possess advanced controls within the CT module, including the authority to assign both internal and external reviewers, create committee meetings, assign specific applications to those meetings, and announce and run the scheduled sessions.

System Requirements

The SAHPRA portal works best with:

  • Google Chrome and Mozilla Firefox
  • JavaScript enabled
  • A standard PDF viewer for interacting with uploaded application documents